The drug is administered subcutaneously ... investigating treatments for people living with hemophilia. In April, the FDA approved Pfizer’s Beqvez, a one-time gene therapy for patients with ...

The US Food and Drug Administration (FDA) has approved Hympavzi ... Marstacimab is Pfizer's second hemophilia approval in 2024. FDA approved the company's hemophilia B gene therapy fidanacogene ...

FDA approves Pfizer’s Hympavzi for routine prophylaxis in hemophilia A and B patients, offering a once-weekly dosing via auto-injector pen. Phase 3 trial showed Hympavzi reduced bleeding rates ...

Based on these results, the FDA approved this drug for a similar indication ... decision marks the second EC approval for Pfizer this year in the hemophilia space. Earlier in July, the FDA ...

Hympavzi, made by Pfizer, is the first antitissue-factor pathway inhibitor to be approved for the blood-clotting disorder, as well as the first hemophilia ... of the FDA's Center for Drug ...

Qfitlia reduced annualized bleeding rates by 71%-73% in hemophilia patients. FDA also approved Siemens Healthineers’ INNOVANCE Antithrombin assay as a companion diagnostic to measure AT levels ...

The U.S. Food and Drug Administration has approved ... with hemophilia because it can be administered less frequently than other existing options,” said Tanya Wroblewski, M.D., deputy director of the ...

Pfizer Inc. has won regulatory approval for its hympavzi drug as a treatment for hemophilia A or B without inhibitors — making it the first antitissue-factor pathway inhibitor to be allowed for ...

Earlier this year, FDA approved Pfizer’s Beqvez (fidanacogene elaparvovec-dzkt) for moderate to severe hemophilia B in adult patients who currently use factor IX (FIX) prophylaxis therapy or ...